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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The study was carried out in two parts. The first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation (Part I) and the second part (Part II) started in 2006 after the tablet formulation became available in participating countries.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

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Reporting Groups

Description

Tablets and Capsules or Oral Solution

HIV-1 infected participants who received both tablet and capsule formulations or oral solution.

Capsule Formulation

Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.

Tablet Formulation

Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

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Reporting Groups

Description

Total Study Population

HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.